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Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01365507
First received: May 31, 2011
Last updated: October 31, 2014
Last verified: October 2014
  Purpose

This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) in combination with metformin.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: IDegAsp
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp Simple
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
Drug: IDegAsp
IDegAsp injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Experimental: IDegAsp Step wise
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Drug: IDegAsp
IDegAsp injected subcutaneously (under the skin) once daily. Dose individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
  • Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
  • Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
  • BMI (Body Mass Index) below or equal to 45 kg/m^2
  • Ability and willingness to adhere to the protocol including self measurement of plasma glucose

Exclusion Criteria:

  • Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
  • Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
  • Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
  • The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
  • Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365507

  Hide Study Locations
Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chino, California, United States, 91710
Novo Nordisk Clinical Trial Call Center
Concord, California, United States, 94520-1926
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, United States, 92262-6972
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
United States, Florida
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32209-6511
Novo Nordisk Clinical Trial Call Center
Orange Park, Florida, United States, 32073
Novo Nordisk Clinical Trial Call Center
Pembroke Pines, Florida, United States, 33027
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Crestview Hills, Kentucky, United States, 41017-3464
Novo Nordisk Clinical Trial Call Center
Madisonville, Kentucky, United States, 42431-1661
Novo Nordisk Clinical Trial Call Center
Paducah, Kentucky, United States, 42003
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
Novo Nordisk Clinical Trial Call Center
North East, Maryland, United States, 21901
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, United States, 48235
Novo Nordisk Clinical Trial Call Center
Troy, Michigan, United States, 48085-5524
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Eagan, Minnesota, United States, 55123
United States, New York
Novo Nordisk Clinical Trial Call Center
Smithtown, New York, United States, 11787
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheboro, North Carolina, United States, 27203
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77070
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Milwaukee, Wisconsin, United States, 53209
Korea, Republic of
Seoul, Korea, Republic of, 152-703
Malaysia
Kota Bharu, Kelantan, Malaysia, 16150
Mexico
Monterrey, Mexico, 64460
Thailand
Bangkok, Thailand, 10400
Turkey
Antalya, Turkey, 07058
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01365507     History of Changes
Other Study ID Numbers: NN5401-3844, U1111-1117-0558
Study First Received: May 31, 2011
Last Updated: October 31, 2014
Health Authority: Malaysia: Drug Control Authority (DCA)
Mexico: National Institute of Public Health, Health Secretariat
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Ministry of Public Health
Turkey: Ministry of Health Drug and Pharmaceutical Department
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014